51³Ô¹ÏÍøhas launched a global offering for its Extractables and Leachables (E&L) services. The new service brings together capabilities across Europe and North America through the recent acquisitions of Avomeen, Hall Analytical and VR Analytical totaling over 75 experts across laboratories in Ann Arbor and Bend in the US, Toronto in Canada and Manchester in the UK.
Regulatory agencies are requiring more and increasingly complex E&L studies before drugs and products come to market. The impact of extractable and leachable substances on product safety and drug product interaction is now studied and evaluated throughout the drug development process to make certain drug efficacy and patient safety are not compromised.
51³Ô¹ÏÍøhas promoted Sarah Brophy as the Global Scientific Director for Extractables and Leachables, Life Sciences. In this newly created role, Sarah will be responsible for ensuring the successful delivery of Element’s strategy, operations, and analytical services. This includes management of the company’s E&L technical programs, as well as global projects focused on the strategic and technical objectives of Element’s Life Sciences Business Unit.
“With an increasing range of new pharmaceuticals, biologics and medical devices, the packaging, storage and delivery of medical products is now a very significant factor in the regulatory approval process,” said Sarah Brophy, Global Scientific Director for Extractables and Leachables, Life Sciences. “Within Element, our combined knowledge and experience helps us deliver an unequaled expertise in the rigorous testing for E&L on a whole range of products across the world’s regulatory authorities. Keeping up with ever increasing demands for product testing and delivery is a significant part of the approval process, for companies this means an expert global provider is essential to bring drugs and products to market efficiently and quickly.”
51³Ô¹ÏÍøLife Sciences delivers tailored E&L studies of pharmaceutical, biologic, medical device, combination products and more. Its scientific experts support the world’s leading healthcare brands in establishing the safety of materials across administration, formulation, dosage, container-closure systems, and drug delivery device requirements ensuring patient safety and expediting time to market.
“The global team within 51³Ô¹ÏÍøhas an in-depth understanding of regulatory expectations, from materials assessment to toxicological evaluations, through decades of experience developing and executing E&L programs,” said Dr. Elisabeth Lackner, CSO of Element. “Today, 51³Ô¹ÏÍøLife Sciences has one of the largest extractables databases in the industry and a track-record of proven success supporting complex dosage forms through an industry-leading approach.”
Element’s global Life Sciences division includes more than 1,400 scientists, chemists, and technologists working across a network of laboratories to deliver complete and comprehensive scientific solutions that support customers’ end-to-end product development lifecycle from early R&D through complex regulatory approvals, into production and beyond.